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A Flawed Flu Papers Process?

Concerned. NSABB member Michael Osterholm has critiqued the process for reviewing controversial flu papers in a new letter.

Courtesy of the University of Minnesota

Last month, one-third of the members of the U.S. National Science Advisory Board for Biosecurity (NSABB) disagreed with the group's recommendation to publish in full two studies that describe how to make the bird flu virus transmissible in mammals. Now one of the six dissenters, influenza epidemiologist Michael Osterholm of the University of Minnesota, Twin Cities, has written a sharp critique of the meeting that led to the decision. In a letter sent yesterday to Amy Patterson, an official at the U.S. National Institutes of Health whose office oversees NSABB, Osterholm charged that the meeting was "designed to produce the outcome that occurred."

Osterholm and the other dissenters in particular had strong concerns about a study led by Ron Fouchier of the Erasmus MC in Rotterdam, the Netherlands, which is under review at Science. Osterholm's seven-page letter, obtained by Science, recounts many arguments he has made publicly before about the need to redact details of the Fouchier group's experiments in ferrets, a model used to study how influenza viruses behave in humans. But Osterholm's letter adds new scientific detail to his concerns and also spells out why he believes the meeting set a bad precedent for future NSABB deliberations. "While I don't suggest that there was a sinister motive by the [U.S. government] with regard to either the agenda or invited speakers, I believe there was a bias toward finding a solution that was a lot less about a robust science- and policy-based risk-benefit analysis and more about how to get us out of this difficult situation," wrote Osterholm.

On the scientific front, Osterholm revealed that Fouchier has new data, which is not in his current manuscript, that makes it even simpler for others to create a mutant version of the H5N1 avian influenza virus that transmits in ferrets. He contends that attempts to publish this work will raise all the same issues that the group wrestled with for the past 6 months, and he predicts that paper "will prove to be the straw that breaks the camel's back." The current NSABB decision, he complained, "just kicked the can down the road to the next manuscript."

The 2-day meeting itself, Osterholm argues, did not offer an "objective review provided by a disinterested subject matter expert" about the ease with which groups with bad intentions could learn how to engineer an H5N1 that transmits in humans. The experts at the meeting who did address these scientific issues, charges Osterholm, "have a real conflict of interest in that their laboratories are involved in this same type of work and the results of our deliberations directly affect them, too." He called a briefing that NSABB members received from intelligence experts "one of [the] most incomplete and, dare I say, useless classified security briefings I've ever attended."

Susan Ehrlich, a retired judge and NSABB member who also voted against publishing Fouchier's manuscript in full, says Osterholm's letter "thoughtfully presents very valid points, ones that warrant further and serious discussion."

Osterholm's letter is available in full.